Blog Archives

Via email from Adriane Fugh-Berman, selected abstracts for talks to be given at the third annual PharmedOut conference June14-15 at Georgetown University. Please see my previous post for more information.

In drafting what would become the 1976 Medical Device Amendment, framers of the legislation sought to avoid some of the perceived shortcomings in the Kefauver Harris Drug Amendments which had been enacted after the thalidomide disaster in 1962. In particular, they wanted to minimize adverse effects on an industry characterized by change and innovation. At that time, however, there was no formal field of biomedical engineering while entrepreneurial zeal had begun to create indisputable regulatory issues. Two of FDA’s first device “hires,” in fact, were a pair of engineers from NASA who concluded after a week on the job that conditions in the biomedical industry at that time were “appalling” and that standard engineering practices including back up systems, redundancies, and performance standards were simply non-existent. Their insights, along with some early lessons learned “the hard way,” helped determine the unique ways in which FDA came to perceive its role in regulating medical devices, ways which differed markedly from those adopted for the regulation of new drugs.

Direct-to-consumer advertising of prescription medicines (DTCA) is arguably the most intensive “educational” campaign the US public receives on health issues. On average, Americans spend over 100 times as long watching TV ads about medicines as seeing a doctor each year. These ads include powerful messages about how to recognize and treat everyday and serious health problems, thresholds for care, the role and value of medicines, and expected health effects. Because the aim is to sell a medicine, this “education of a special kind” consistently supports overuse of medicines. I will use examples of recent DTCA campaigns to illustrate the gulf between the scientific evidence on treatment effects, appropriate use, and advertising messages.

Cardiovascular Devices: The Role of Evidence in the FDA Approval Process
Rita Redberg, MD, Archives of Internal Medicine and UC San Francisco

There has been a rapid increase in complexity and use of medical devices, and many of them are cardiovascular. While some of these are life-saving, some are not, and even more have unknown clinical benefit. The current state of the quality of evidence prior to FDA approval of high-risk devices, with some examples and suggestions on how to improve this process so that patients could be more assured of benefits outweighing harms will be discussed.

Left To Our Own Devices: A Surgeon’s Perspective
Amy Friedman MD, SUNY Upstate Medical University

A practical overview of the extent to which the typical clinician comprehends the regulatory pathway for medical devices will be presented. The extent to which clinicians are (or are not) familiar with the specific level of scientific data review that the medical devices they use in patients have undergone prior to gaining FDA clearance for human use will be illustrated. Two specific examples of medical devices that have been associated with significant patient harm, but were not previously recognized to be of concern will be used to illustrate the context of unknown patient safety and risk in the clinical arena.

Many clinicians are unaware of the amount of radiation delivered from CT scans and other medical imaging techniques and extant data regarding increased risk of cancer from radiation exposure. This presentation will cover the long-term risks of radiation from medical imaging, legislative and quality improvement efforts around CT imaging, and present a framework for reducing inappropriate imaging.

The Failure of the DePuy ASR Hip Prosthesis: Implications for device safety initiatives
John Restaino, DPM, JD, MPH, University of South Carolina School of Pharmacy

The use of metal-on-metal bearings in total hip replacements has seen a sharp decline after a decade-long increase in their use, due to the recall of DePuy’s ASR prosthesis and the growing realization that metal-on-metal prostheses are associated not only with a high failure rates but also elevated systemic cobalt and chromium levels. In the U.S., the ASR XL total hip replacement passed through the FDA’s 510(k) clearance process via the “substantial equivalence” route wherein companies need only to show that their product is similar to a ‘predicate’ device already on the market. In 2007 the Australian National Joint Replacement Registry reported that the ASR required revisions at a rate five times the expected rate at two years. Following years of denial by DePuy that ASR implants were failing, ASR hip prostheses were recalled from the U.S. market on August 24, 2010.

The Supreme Court Strikes Back: IMS v. Sorrell – a Constitutional Right to Track Prescription Data?
Sean Flynn, JD, American University Washington College of Law

The Supreme Court ruled in IMS v. Sorrell that Vermont’s law restricting the use of prescription data to target pharmaceutical detailing to doctors violated the First Amendment of the Constitution. How broad is the right recognized? What room is left for states to control commercial access to confidential medical data for marketing purposes?

The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) provides oversight for the Medicare and Medicaid programs. This presentation will offer an overview of OIG efforts, via audits, evaluations, inspections, and enforcement actions, to combat unnecessary or harmful medical care.

For years pharmaceutical companies have paid marginalized populations to test the safety of new drugs. In recent years, however, specialized psychiatric trial sites have begun recruiting mentally patients from homeless shelters, boarding houses and recovery facilities. These subjects are often paid to test the safety of new drugs in Phase I trials, raising new ethical questions about exploitation of vulnerable populations.